Ampligen Has anyone tried this?

Discussion in 'Fibromyalgia Main Forum' started by PVLady, Jul 9, 2008.

  1. PVLady

    PVLady New Member

    I found this current on the ProHealth news about Ampligen. Does anyone have thoughts on this? Thanks...

    FDA accepts antiviral drug AmpligenR for review as first-ever ME/CFS (‘chronic fatigue syndrome’) therapeutic


    July 8 – After 30 years in development and testing, the experimental “antiviral/immune modulatory” drug AmpligenR has been accepted by the FDA for review as potentially the first prescription drug approved in the U.S. for treatment of ME/CFS – specifically for certain patients with severe ME/CFS.

    Delivered intravenously, typically twice weekly over a year or more, AmpligenR (AMPLified GENetic activity) has been available in Belgium and Canada for ME/CFS and HIV treatment since 1996.

    AmpligenR (polyI:polyC12U) - still allowed only in specific clinical trial settings conducted under U.S. governmental authorization - is termed “a nucleic acid drug,” designed to “modulate” the body’s immune system. Its mechanism of action in ME/CFS “is not entirely clear,” but it is thought to act on two enzyme systems so as to help the immune system destroy viral RNA and speed the death of virus-affected cells.

    In particular it may “downregulate” an anti-viral pathway which research suggests has become “upregulated” in certain ME/CFS patients (the 2-5 Synthetase/RNase L anti-viral pathway).

    The drug’s maker – Philadelphia-based Hemispherx Biopharma, submitted a New Drug Application to the FDA in 2007, and had been asked to answer a series of questions. The FDA’s acceptance of the drug for safety/efficacy review was based on receipt of the requested data. The maker reportedly suggests it is also researching oral delivery of the drug.

    A "Who's-Who" of the world’s leading ME/CFS specialists have participated in AmpligenR trials over the years.

  2. marti_zavala

    marti_zavala Member

    I would research the archives. I know it was discussed on CFSFMExperimental during those years of the clinical trials.

    It was like Valcyte - very harsh but I don't remember the outcome. I think it helped some and not others.

    It was very expensive.

  3. kbak

    kbak Member

    I don't believe anyone here has tried it. You might want to go on goggle and see if you can find anyone who has experience with it. I think it's going to be a case of it working well for some but not for everyone, but at least their finally letting some new drugs in.

    Take care,
  4. Khalyal

    Khalyal New Member

    (Nancy Kaiser, known as Patient 00, died from end stages of CFS on June 14 of this year)
    "For 18 years, FDA has been telling us Ampligen is "18 months from approval". At least they’re consistent. But that’s an additional 18 years that patients have continued to suffer while the government plays games"

    Wednesday, July 25, 2007
    2:43:00 AM EDT More on the NYT Article & Ampligen

    A letter from CFS patient Nancy Kaiser to the author of the NYT article (which was also published elsewhere) suggests reviewing the website of The National CFIDS Foundation, click on Medical Discoveries.

    Nancy also quotes extensively from "Osler's Web" which she calls "my story of the battle with this illness. I was sort of the poster girl for being as sick as you can get with this disease(I still am)" "My story was also the lead story in the Newsweek article from November 12, 1990 -- plus then carried a few months later in Reader's Digest." Nancy was one of the first patients to receive Ampligen in clinical trials.

    (The entirety of Nancy’s extremely lengthy response is available on It is much too long for the size limit on blog posts here, so I feature only excerpts.)

    * The loss of Stat1 in patients with this disease has been confirmed by three independent research groups [DeMeirleir; Suhadolnik; Knox and Carrigan]. Loss of Stat1 constitutes a serious illness that may ultimately be fatal due to the fact that this leaves the patient unable to fight bacterial and viral infections thereby resulting in severe immune deficiency [Dupuis; Durbin]. Patients are frequently seen with multiple secondary opportunistic infections with researchers labelling this disease as a form of AIDS [Klimas].

    * Immune disruptions have been frequently documented in these patients as evidenced by abnormal changes in CD4/CD8 ratio, absolute changes in lymphocyte or T-cell counts (typically lymphopenic); changes in CD19 B-cell counts either diminished (Common Variable Immune Deficiency/CVID) or increased (Leukemia). [Uckun; Johnson; Hilgers].

    * Dramatic alterations to circulating blood volume have added to further restrict patient daily activities [Streeten] with exercise capacity and performance directly related to immune dysfunction [Snell; Nijs; DeBecker]. Abnormal changes in heart rate and blood pressure are frequently present [Streeten].

    [ The following are excerpts from the book "Osler's Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic" by Hillary Johnson, Crown Publishers, Inc., 1996. ] All text ©1996 by Hillary Johnson

    p. 254 (1988) Since the local epidemic, Peterson had been an avid reader of the AIDS medical literature, scouring journals for studies about the better-studied immune disorder in hope of finding therapies for his own patients. ... Aside from Ampligen's apparent clinical safety, Peterson noted that the test subjects who fared best were those who had yet to advance to full-blown AIDS -- the AIDS-related complex sufferers -- whose clinical symptoms were virtually indistinguishable from those of chronic fatigue syndrome sufferers.

    p. 355 (1989) Additional testing revealed that those patients who responded well to Ampligen had a deficit in the body's natural antiviral defense system. David Strayer had found the same deficit in AIDS sufferers who responded well to Ampligen. Peterson and Strayer suspected this defect might eventually become the diagnostic hallmark that had been sorely lacking in CFS.

    p. 506 (1991) Few placebo recipients demonstrated improvement; in fact, several deteriorated during the six months of the trial.

    *Their deterioration may have been due to the fact that they were required to stop taking all other medications in order to participate in the trial. In addition, simply getting to and from the infusion site two or three times a week [frequency was determined by dose; not all patients received identical dosages] amounted to tremendous exertion for CFS patients and may have exacerbated their disease. The forty-five people who received Ampligen were demonstrably better. The outcome was so dramatic, in fact, that HEM decided to end the trial after just twenty-four weeks rather than the forty-eight weeks it had first planned. For instance, there had emerged strong evidence that interleukin-1, a substance manufactured by the immune system in response to viral infection, might be a marker of disease severity. Patients who received Ampligen experienced a reduction in interleukin-1 as well as a reduction in symptoms. In addition, in 1994, Temple University School of Medicine biochemist Robert Suhadolnik and other clinicians and scientists who collaborated on the trial published a study reporting that the drug ameliorated a defective antiviral pathway common to CFS patients.

    *Robert J. Suhadolnik et al., "Changes in the 2-5A Synthetase/Rnase-L Antiviral Pathway in a Controlled Clinical Trial with Poly(I)-Poly(C12U) in Chronic Fatigue Syndrome," In Vivo 8 (1994): 599-604.

    "Poly(I)-Poly(C12U) is the molecular name for Ampligen. Before treatment with Ampligen, the molecular indicators for damage to this pathway were "significantly elevated" compared to those of controls. (This finding was yet another link between CFS and AIDS; victims of AIDS suffered an identical defect.) After treatment, these molecular indicators were vastly improved in CFS sufferers, as they had been in AIDS patients after Ampligen treatment, and Suhadolnik and his co-authors noted that they corresponded with "clinical and neuropsychological improvements."

    None had been restored to a degree of health that had allowed them to return to their jobs. Even more problematically, among those who were taken off the drug temporarily, for whatever reason, the disease had become significantly worse, suggesting that to derive benefit patients needed to be maintained on Ampligen indefinitely and that withdrawal from the drug could actually exacerbate symptoms. By the third and fourth week off the drug, patient who had been confined to wheelchairs before they entered the trial were returned to their wheelchairs; almost everyone was again housebound.

    p. 520 (1991) Few involved in the struggle to bring Ampligen into the marketplace failed to appreciate the larger political issue that had emerged along with the promising results of the clinical trial. One arm of the nation's federal health establishment, the Food and Drug Administration, was being asked to rule on the use of a potent antiviral drug for a disease the Centers for Disease Control and the National Institutes of Health had dismissed for years as a psychiatric condition. The ramifications of the FDA's decision were hardly lost on patient advocacy groups. "If Ampligen is approved for treatment of CFIDS," the CFIDS Association in Charlotte had told its 25,000 members in a special mailing that summer, "this will be a monumental step toward gaining credibility and focusing more attention and research on CFIDS." At the same time, Paul Cheney noted, "The FDA is really in a bind. If the agency approves the treatment IND application, they will, in one swoop, destroy the credibility of two government agencies."

    p. 534 (1991) Anthony Komaroff told the reporter, "This isn't a medicine that acts on the psyche. It acts on the body." On the eve of the FDA's response to HEM, Paul Cheney and Dan Peterson, independent of one another, were gloomy about the drug's prospects. "There's not a chance the Food and Drug Administration is going to approve this drug," Peterson said over dinner the night of Carter's presentation. "How can they approve a drug for a disease the NIH says doesn't exist?" Cheney predicted the agency would "probably delay approval pending toxicity issues, but it's just a way to delay. They don't have the guts to kill it, because the patients will kill them. But they don't have the guts to approve it, because Straus will kill them." "To approve Ampligen would be the single most powerful blow for the credibility of this disease," said Marc Iverson, the CFIDS Association's president. "This was not a decision based on science. It was politics." In a newsletter published later that fall, the CFIDS Association's executive director, Kim Kenney, wrote, "We suspect that this is a delay tactic employed by the FDA to prevent the approval of an antiviral drug by one governmental agency for an illness that another, namely the NIH, still considers to be simply depression by another name."

    p. 647 (1994) ]"It's a miracle drug. I know AIDS patients who were being maintained on this drug and died immediately when they took them off[/b]. Here was a massive, million-dollar investment with good results," Suhadolnik added in reference to the four-city CFS trial. "Why didn't it meet FDA approval? It's just plain crazy." After a moment he added, "The biggest problem that drug has is that it works."
    This page is maintained by Roger Burns of Washington, D.C. E-mail:

    * * * *

    For 18 years, FDA has been telling us Ampligen is "18 months from approval". At least they’re consistent. But that’s an additional 18 years that patients have continued to suffer while the government plays games.

    Dr. Jose Montoya of Stanford has come up with an alternative – an anti-viral that’s already FDA approved, which has produced remarkable results that Dr. Montoya deemed a "cure".

    As Dr. Komaroff observed, these are not drugs that work on the psyche – these are drugs that treat the viral infection that patients report triggered their problems, and that many doctors refuse to accept as being connected to the symptoms. This is not depression by another name. This is a disease that was once referred to as "AIDS Lite" because of its many similarities to AIDS, which appeared on the scene just a few years before the Incline Village epidemic.

    But, in fact, "AIDS Lite" is – according to experts who treat both – more disabling than AIDS. Dr. Mark Loveless, an infectious disease specialist and head of the CFS and AIDS Clinic at Oregon Health Sciences University, proclaimed that a CFIDS patient "feels every day significantly the same as an AIDS patient feels two months before death."

    AIDS got respect only when patients began dying; before that, it was written off to patients simply being depressed because they were gay. When I was diagnosed with CFS, I was given the good news that CFS wouldn’t kill me ... every patient who had died "of CFS" had committed suicide. Now, 20+ years out, we have CFS patients beginning to die of heart failure, cancer, opportunistic infections (which is the same thing that kills most AIDS patients). How many deaths will it take to wake people up that this is a serious disease that requires serious drugs?

    Anti-depressants have repeatedly been proven to work only on patients who have concomitant depression. They relieve the depression enough to sort out how much of the symptoms is caused by depression and how much by CFS. In some cases, the depression overlay was what was preventing the patient from working, because the CFS symptoms were comparatively mild.

    However, only 60% of CFS patients also have depression. The other 40% show no benefit at all from psychiatric drugs, because their problem is purely physical. Anti-depressants do nothing at all for me, other than making me sicker, and repeated psych evaluations have confirmed that I am not depressed: they have unanimously pointed out that the "symptoms of depression" noted by MDs (most notably fatigue) are also symptoms of the flu – the emotional symptoms (low self-esteem, loss of interest/enjoyment, suicidal ideation, etc.) are entirely missing in my psych profile. I’m still interested in doing the things I love, I just, physically, cannot do them; I start projects but lack the stamina to finish. Those are not typical of depression, where the initiative to start is missing.

    I enjoy life as much as possible, but when you’re mostly confined to bed and the few things you do are chores, there’s not a lot of Quality of Life to be enjoyed. For someone who used to love to dance, play baseball and volleyball, go biking, and take long walks, there’s not much Quality of Life to be had in watching bad TV 20 hours a day because you can’t even focus on a magazine article, and watching life pass you by while waiting for someone to do something to make you well. But saying "I hate watching TV" is not the same thing as being depressed. It means that I still have the initiative (if not the physical ability) to want to dance.
    [This Message was Edited on 07/10/2008]
    [This Message was Edited on 07/10/2008]
  5. marti_zavala

    marti_zavala Member

    this timing is more than coincidence.

    The genetic polymorphism study done by the CDC in 2005 was when they started to change their minds about this being a real illness. I didn't hear an apology, did you.

    Guess then they had to let Ampligen go through.

    It is a travesty. It is just wrong. But it is not over yet, the CDC is leaning towards the UK's NICE guidelines which is back in the psychologial world.

  6. PVLady

    PVLady New Member

    Thank you for the responses. I am still trying to learn and it is very confusing sometimes....

  7. Khalyal

    Khalyal New Member

    And yes, Dr. Reeves et al at the CDC are pushing hard to put a psychological slant on CFS.

    Dr. James Jones, a leading virologist at the CDC, is all of a sudden an authority on psychoneuroendochrinology and allostatic stress loads as far as CFS is concerned. He is producing theory papers for the CDC that are leaning heavily toward CBT.
  8. TeaBisqit

    TeaBisqit Member

    Twenty years ago. It should have been our decision whether or not to try it.

    I hope they eventually make a pill out of it and that those who would benefit from it, will get it.

    It's a heartbreaking tragedy that there is a drug that could help us and all these years it has been held back from us.